Whether or not an IT service provider is considered to be part of a test facility by a GLP compliance monitoring authority will depend on various factors including the extent of the service provider’s involvement in GLP studies. If they are part of a test facility then the GLP compliance monitoring authority may also decide that they will be subjected to GLP inspections.
Depending on the services provided, audits by test facility management may be necessary for the contracted IT service. These may include the assessment of its computerised systems management, in general, and of the specific computerised systems, where such systems impact a study (e.g. risk assessment, validation approach and qualification). Suppliers are addressed in detail within OECD Document No 17, paragraphs 34 – 40.
